List Of SOPs

1.0 PURPOSE

To provide an Instruction for Sampling, testing and approval of raw material.

2.0 SCOPE:

This procedure is applicable to all quality control laboratory.

5.0 PROCEDURE:

5.1 Analyst/Designee QC shall allot the sample; if any material requires additional care (such highly hygroscopic or sensitive) allot the sample to sampling personnel who is qualified for that material sampling.

5.2 Sampling personnel shall pick up the sample observation sheet; Additional control measures or checklist can be used as per location specific policy.

5.3 If material received first time sampling personnel shall fill the details, as mentioned in the “sampling observation on sampling area and pack” and get it authorized by QC and QA manager or designee.

5.4 Before proceeding for sampling, sampling personnel shall arrange for required sampling tools in the sampling kit. Wherever applicable, dedicated sampling tools to be used for sampling.

5.5 Clean and dry stainless-steel spoon/scoops and sampling thieves shall be used by sampling personnel for sampling of solids and clean and dry pipettes/liquid sampler for sampling of liquids.

5.6 Analyst/Designee QC shall use clean poly bags for collecting solid sample from individual containers pooled sample and reserve samples.

5.7 Analyst/Designee QC shall use black polybags /amber bottles for collecting light sensitive materials.

5.8 Use spoons/scoops/sampling thief sanitized with Isopropyl alcohol and sterile polythene bags/containers/ glass bottles to collect samples for microbial testing.

5.9 Analyst/Designee QC shall check and ensure validity to use the bottle by verifying the date of sterilization mentioned on the sterilized glass bottle. Check for any condensate present in the bottle. If condensate is found, do not use the bottle and send for disposition.

5.10 Use the same sampling tools for collecting the chemical samples also, if samples are to be collected for both, after sampling of microbiology samples; refer sr. no 5.9.

5.11 Analyst/Designee QC shall carry required number of blank labels indicating the status of sample.

5.12 Analyst/Designee QC shall carry clean polythene bag to carry out used sampling tools after sampling.

5.13 Pre- Sampling checks

5.13.1 Analyst/Designee QC shall refer to the specification or standalone list for quantity to be sampled.

5.13.2 Analyst/Designee QC shall enter the warehouse department as per ware house entry and exit procedure

5.13.3 Identify the consignment with the help of warehouse personnel and verify the storage conditions and the packaging instructions. Record the details in the sampling observation sheet.

5.13.4 Analyst/Designee QC shall verify whether “Under Quarantine” labels have been affixed on all containers and manufacturers / suppliers approved labels are defaced.

5.13.5 Analyst/Designee QC shall check and ensure that all the containers received are in good condition

5.13.6 Make relevant entries in the ‘Sampling observation sheet’.

5.13.7 Prepare relevant labels as mentioned;

5.13.8 Analyst/Designee QC shall verify the details on “Under Quarantine label” and manufacturer/suppliers label against MRV/COA/COC and make relevant entries in the sampling observation sheet for Raw materials. Verify these details on “Material label” in case of MTAS.

Note: In case of any difference in the details of the label & the supplier COA, handle.

5.13.8 Analyst/Designee QC shall identify the containers for sampling and arrange the identified containers to be transferred to the material entry hold area of the sampling booth.

5.13.9 Analyst/Designee QC shall sample as per authorized sampling plan. Update sampling plan as and when required (Standalone document);

5.13.10 Analyst/Designee QC shall perform 100% sampling from all the received containers for API and √n+1 from all the received containers for excipients.

5.13.11 Reduced sampling can be followed if approval available from concerned regulatory agency or on special cases based on material stability;

5.14 Sampling Procedure

5.14.1 Analyst/Designee QC shall enter the sampling Booth /Isolator area as per entry exit procedure for sampling booth/ Isolator area.

5.14.2 Use the PPEs like Gloves, Mask, Goggles and Cap before sampling. Once hand gloves are under use, do not come in contact with floor or wall. In case hand gloves come in contact with floor or wall sanitize the hands with disinfectant available in change room of sampling booth. Clean the goggles with lint free cloth before next usage as applicable.

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1.0 PURPOSE

To lay down a procedure for operation and calibration of vacuum oven.

2.0 SCOPE:

This SOP is applicable for operation and calibration of vacuum oven in the Quality Control laboratory.

5.0 PROCEDURE:

5.1 OEPRATING PROCEDURE:

5.1.1 Ensure the vacuum oven is clean, properly placed and checked for calibration status

5.1.2 Connect the power cable and switch ‘ON’ the supply.

5.1.3 To set the temperature press key button temperature controller.

5.1.4 While pressing the button, press the button buttons until the desired set temperature is shown.

5.1.5 After increase or decrease, press button and the actual temperature will again be displayed.

5.1.6 The unit will now adjust the new set temperature is attained after 5 to 10 minutes.

5.1.7 Keep the materials on the trays, inside the oven and close the door tightly.

5.1.8 Unscrew the top screw knob to create vacuum and attach the vacuum pump tube, switch it ‘ON’.

5.1.9 When the desired pressure is shown on the pressure gauge, remove the vacuum tube and close knob.

5.1.10 After the desired time switch ‘OFF’ unscrew the knob to release the pressure slowly.

5.1.11 Then open the door and take out the sample carefully.

5.1.12 Record the activity in Vacuum oven logbook as per in annexure -1

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1.0 PURPOSE

To lay down a procedure for operation and calibration of Melting point apparatus.

2.0 SCOPE:

This procedure is applicable for operation and calibration of Melting point apparatus in the Quality control department.

5.0 PROCEDURE:

5.1 Operating procedure for melting point

5.1.1 Keep the apparatus on a stable table by an electrical supply

5.1.2 Fill silicon oil in the beaker up to the level mark

5.1.3 Place the magnetic rotor in the beaker.

5.1.4 Place the glass beaker filled with oil and rotor in the beaker housing and cover the beaker with the Teflon lid which is fitted with an immersion heater and PT-100 sensor.

5.1.5 Connect the heater to the heater socket and temperature sensor to the sensor socket provide on the apparatus, with the attached cable.

5.1.6 Put powder to be tested in the capillary and tap lightly to gather the powder at the bottom. Wipe the outer surface of the capillary to remove powder particles that can contaminate the oil in the bath.

5.1.7 Insert the capillary filled with the powder sample through one of the sample holes in the Teflon cover of the beaker and do same for other capillaries.

5.1.8 Keep the heater-controlling knob of the apparatus to its minimum and connect the cable to the mains supply.

5.1.9 Put the mains ON

5.1.10 Look through the magnifying lens attached to the apparatus to see the capillaries. Rotation of the Teflon cover can be done for better visualization.

5.1.11 Use the control on the rear right of the instrument to control intensity of brightness.

5.1.12 Press on the START key, the green pilot lamp and red indicating lamp will glow indicating that the heater is on.

5.1.13 Turn the heater control knob fully clockwise (Two positions are switch is provided to boost the heating of the oil bath. The LOW position is selected for melting points up to 200⁰C and HIGH for higher melting points).

5.1.14 Keep the switch at HIGH, the temperature starts rising, the indicator lamp glows with Full intensity, and when temperature is about 30⁰C below expected Melting point of the powder, set the switch to LOW position and reduce the heating rate by turning the knob anticlockwise.

5.1.15 Adjust the heating rate suitably to about 1⁰C per minute prior to 10⁰C of melting point.

5.1.16 Watch at the tips of the capillaries containing samples under test. At the exact stage when the desired sample melts, Press the STOP switch to arrest the digital reading from changing. Green and indicator lamp are switched off. Note the reading.

5.1.17 Press the CLEAR switch, the digital display would show the current temperature of the oil-bath.

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1.0 PURPOSE

To lay down procedure for operation of water bath.

2.0 SCOPE:

This procedure is applicable to the water bath available at Quality Control Laboratory

5.0 PROCEDURE:

5.1 Operation procedure:

5.1.1 Ensure the water level is above the heating coil or 3/4th of the water bath capacity.

5.1.2 Switch on the power. Set the desired temperature on the digital controller by pressing keys and set the temperature by using increase and decrease keys.

5.1.3 The display screen shows the actual temperature when hand is removed from the keys.

5.1.4 Switch off the water bath after usage.

5.1.5 Record the details in water bath log book as per Annexure-1

5.2 Calibration procedure:

5.2.1 Use temperature control and comber to calibrated thermometer to calibrate the instrument.

5.2.1 Read the actual temperature on the controller against the set temperature on the water bath.

5.2.2 If the results of calibration found satisfactory note down the results in the water bath calibration record as per Annexure-2.

5.2.3 Affix calibration status label refer to work instruction “management of laboratory instrument and equipment”

5.2.4 In case of any failure during usage, refer to user manual or call the service engineer for reflection and label the instrument as “under maintenance “.

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1.0 PURPOSE

To provide guidelines to ensure safe practices are followed in QC Department

2.0 SCOPE:

This procedure is applicable to safety procedures to be followed in the Quality Control Department (Chemical/ Instrument and Microbiology Section).

5.0 PROCEDURE:

5.1 Chemical Hazard

5.1.1 Any Solvent (Volatile solvents and corrosive liquids) shall not be pipetted directly with mouth. Withdraw it with the help of sucker in fuming hood only.

5.1.2 Avoid direct contact of corrosive chemical with body surface. Ensure the handling carefully using hand gloves.

5.1.3 Bottles containing strong acids shall be kept in thermocol cases. Acid sample residue shall be washed with plenty of water immediately.

5.1.4 Volatile solvents shall not be poured near naked flame. Use gloves for handling of conc. acids, alkali and corrosive solvents

5.1.5 Glassware shall be washed after emptying the content and flushing with sufficient water to ensure complete drainage of the content.

5.1.6 In case of burns due to acid/chemical, body shower shall be used for washing of burnt skin. In case of any eye irritation due to chemical effect, the eye shower shall be used.

5.1.7 Handle Hazardous reagent and reagents evolving irritating fumes in the fume cupboard only.

5.1.8 In case of spillage of corrosive liquid evacuate the area immediately and it should be diluted with water and mopped with cloth and disinfect the area.

5.2 Lab Glassware:

5.2.1 Do not use broken glassware.

5.2.2 Label the reagent bottle appropriately.

5.2.3 Pour liquid in a direction away from label to avoid spoilage of label, if any liquid spills on outside of bottles; wipe it with clean duster before returning it to shelf.

5.2.4 To remove tight stoppers on chemical / solvent bottles rotate the stoppers alternatively on each side. If this does not work and the contents of the bottle are not flammable or toxic, gently warm the neck of the bottle. In case of flammable solvent use light tapping to loosen the stoppers.

5.3 Environmental Safety

5.3.1 Dilute the Concentrated acids and alkali with water before draining and sufficient water should be flushed after pouring.

5.3.2 Any work involving fumes and harmful gas shall be carried out in fuming cupboard.

5.3.3 Apron, safety goggles, nose mask and cap shall be worn at all times for protection of body and clothes.

5.4 First Aid Measure:

5.4.1 Appropriate first aid shall be given in case of injuries like burn and cuts. The person should then be taken to a medical center for further treatment.

5.4.2 In case of electric shock turn ‘OFF’ the main switch of the area concerned and give appropriate first aid to the person.

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1.0 PURPOSE

To provide an instruction for operation and calibration of Vernier Calipers.

2.0 SCOPE:

This procedure is applicable to the operation and calibration of the Vernier Calipers in the Quality Control Department.

5.0 PROCEDURE:

5.1 General cleaning

5.1.1 Clean the caliper with dry clean cloth before and after use.

5.1.2 Care has to be taken to remove foreign particles from Measuring Faces.

5.1.3 Always keep the caliper in the case.

5.2 Procedure for operation

5.2.1 Switch on the calliper by pressing ON / OFF button.

5.2.2 Press ZERO / ABS button.

5.2.3 Press In / mm button for desired output in inches / millimetres.

5.2.4 Care Check whether the display is 0.00 mm / 0.0000 in as per the mode selected inch (In).

5.2.5 Close the measuring jaws. Read display.

5.2.6 If display is not zero 0.00 mm / 0.0000 in. adjust it to 0.00 mm / 0.0000 in.

5.2.7 Clean the jaws.

5.2.8 Close the jaws completely.

5.2.9 Press the ORIGIN button to get display zero.

5.2.10 Place clean sample in between measuring jaws and close the jaws.

5.2.11 Record the reading displayed

5.2.12 Switch off the display by pressing ON / OFF button.

5.2.13 Take out the sample, clean the jaws and keep the caliper in case.

5.3 Calibration procedure

5.3.1 Calibration of the Vernier caliper will be done through External calibration Service laboratory.

5.3.2 Report for any discrepancy observed in the Calibration report to Department head and Stop using the Caliper. Affix BREAK-DOWN tag to the Caliper and inform to Utility department for rectification.

5.4 Calibration Frequency

5.4.1 Daily Verification: (Accuracy) Once a year and after each Maintenance Job.

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1.0 PURPOSE

To lay down a procedure for Allocation of Analytical Reference Number.

2.0 SCOPE:

This procedure is applicable to Allocation of Analytical Reference Number in the Quality Control Laboratory.

5.0 PROCEDURE:

5.1 Analytical reference number shall be generated when the material / product received in the quality control for analysis

5.2 For Raw Materials & Packaging materials

5.2.1 All analytical reference number for raw materials and packaging materials shall have Fourteen characters.

5.2.2 AR Number for Raw material & Packaging material report will consist of

JSA/ RM/month/Year/Serial Number.

e.g. For Raw material

JSA

RM /

01/

24 /

Serial no.

JSA: Jsa Validation Services

RM: Raw material

/: Slash

01: Indicates the month

24: Indicates the Year

/: Slash

Serial no: Serial number of the material / sample

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1.0 PURPOSE

To lay down a procedure for cleaning of glassware used for Chemical and Instrumentation analysis.

2.0 SCOPE:

This procedure is applicable to cleaning of glassware, which is used for Chemical and Instrumentation analysis in the quality control laboratory.

5.0 PROCEDURE:

5.1 Laboratory assistant must wear protective gloves, goggles for cleaning of the glassware’s.

5.2 All the glassware’s for the analysis shall be cleaned thoroughly before use.All analytical reference number for raw materials and packaging materials shall have Fourteen characters.

5.3 New glassware shall be cleaned using nitric acid followed by tap water and purified water.

5.4 All the glassware’s due for cleaning shall be collected in a tray and transferred in the washing area.

5.5 Glassware’s shall be washed as quickly as possible after use, if delay is unavoidable the same shall be allowed to soak in water.

5.6 Glassware’s shall be washed several times with running tap water, scrubbed with detergent, washed with tap water followed by purified water.

5.7 Grease shall be removed by weak sodium carbonate solution or acetone.

5.8 Strong alkalis shall never be used for cleaning.

5.9 During washing of the glassware’s, all the glassware’s shall be thoroughly scrubbed with nylon brush selected for the shape and size of the glassware.

5.10 All the glassware’s after washing shall be rinsed with purified water & shall be dried in the hot air oven at 60°C.

5.11 Cleaning specific types of glassware’s:

Pipettes

Place pipettes tips down, in a cylinder or tall jar containing detergent solution immediately after use. Make sure that detergentlevel is enough to immerse the pipette.

Clean the pipettes under running tap water and finally rinse with purified water and dry in the hot air oven at 60°C.

Burettes

Remove the Stopcock and wash the burette with detergent solution.

Clean the burettes under running tap water thoroughly & finally rinse with purified water.

Wash the stopcock separately before the stopcock is replaced in the burettes.

Invert the burette & place it in stand for draining and drying.

HPLC Vial and Plugs

Remove the plug and content from HPLC vial and collect the vial and plug in glass beaker.

Wash vial and plug first with running tap water then dip in detergent solution to remove the contamination solution. Remove the detergent solution contamination by using sufficient quantity of running tap water.

Keep the vial in oven for drying purpose.

After complete drying of vial remove it from the oven and keep it in plastic bag or vial box in clean place.

5.12 If required, sonicate the vials and plugs in a beaker filled with methanol or water as required

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1.0 PURPOSE

To lay down procedure of operating and calibrating procedure for UV Spectrophotometer.

2.0 SCOPE:

This Procedure applies to the UV-Spectrophotometer used in Quality Control.

5.0 PROCEDURE:

5.1 Operating procedure:

5.1.1 First turn ON instrument then Double Click on Spectra Manager ICON

5.1.2 Enter user ID and Password click on Logon

5.1.3 Click on UV on right side you will see Status Initialising

5.1.4 Wait till Status Shows Idle

5.1.5 Double click on Spectra Measurement

5.1.6 Click on Measure > Parameters

5.1.7 Set measurement parameters

5.1.8 Click on Correction select Baseline

5.1.9 No one change

5.1.10 Enter sample name and comment here

5.1.11 Click on save this window will open go to desired path give file name and enter password

5.1.12 To open saved parameters click on Open then select desired parameters

5.1.13 Insert Blank in sample compartment then click on Baseline

5.1.14 Click on measure

5.1.15 Spectra of blank will be measured

1.1.16 Place Sample inside sample compartment click on sample

1.1.17 Spectra of sample will be measured

1.1.18 Click on file > Send to Spectra Analysis

1.1.19 Spectra Analysis window will open

1.1.20 Click on Processing > Peak Peak Processing > Peak Find

1.1.21 Click on apply and select desired peaks and delete unwanted peaks

1.1.22 Click OK

1.1.23 Click on Edit > Comments

1.1.24 Enter sample name and details

1.1.25 Click on File > Save Go to desired path give file name and enter password click save

1.1.26 To take print out click on file > Print

1.11.27 Enter the usage details in the UV-visibles log book, as per annexure -1

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1.0 PURPOSE

To lay down a procedure for Personnel entry and exit in Sampling Booth.

2.0 SCOPE:

This procedure is applicable to the Personnel entry and exit in Sampling Booth.

5.0 PROCEDURE:

5.1 Personnel entry in sampling area

5.1.1 Open the door, enter into the sampling Booth Change Room along with sampling kit.

5.1.2 Wear the dedicated Apron, Cap, Mask and Gloves.

5.1.3 Wipe the hands with 70 % IPA.

5.1.4 Switch ON the RLAF

5.1.5 Record the temperature and Humidity in log sheet.

5.1.6 Check the cleanliness of sampling booth prior to sampling.

5.2 Personnel exit from sampling area :

5.2.1 Switch off RLAF after completing the sampling.

5.2.2 Remove the Apron, Cap, Nose mask, Gloves keep it inside the soiled garment Bin.

5.2.3 Open the door of sampling booth Change room and come out from the Booth along with Sampling kit.

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ORAL DOSAGE FORM SOPs

List Of SOPs